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The high pCR rate of sandwich neoadjuvant treatment in locally advanced rectal cancer may translate into a better long-term survival benefit: 5-year outcome of a Phase II clinical trial

Authors Hu YH, Wei JW, Chang H, Xiao WW, Lin JZ, Cai MY, Cai PQ, Kong LH, Chen G, Pan ZZ, Zeng ZF, Ding PR, Gao YH

Received 18 March 2018

Accepted for publication 3 July 2018

Published 10 October 2018 Volume 2018:10 Pages 4363—4369


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Lu-Zhe Sun

Yong-Hong Hu,1,2,* Jia-Wang Wei,1–3,* Hui Chang,1,2,* Wei-Wei Xiao,1,2 Jun-Zhong Lin,1,4 Mu-Yan Cai,1,5 Pei-Qiang Cai,1,6 Ling-Heng Kong,1,4 Gong Chen,1,4 Zhi-Zhong Pan,1,4 Zhi-Fan Zeng,1,2 Pei-Rong Ding,1,4 Yuan-Hong Gao1,2

1State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People’s Republic of China; 2Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China; 3Departments of Oncology, Ganzhou People’s Hospital, Ganzhou, Jiangxi, People’s Republic of China; 4Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China; 5Department of Pathology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China; 6Department of Medical Imaging and Interventional Radiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China

*These authors contributed equally to this work

Background: In a Phase II clinical trial, we reported the effectiveness and safety of a sandwich neoadjuvant treatment based on a modified oxaliplatin plus capecitabine (XELOX) regimen for locally advanced rectal cancer (LARC). The pathologic complete response (pCR) rate was 42.2%, and no patient presented Grade 4 acute toxicities. This study was performed to evaluate whether the high pCR rate could translate into an improved long-term survival benefit by analyzing the 5-year follow-up results of the trial.
Methods: Fifty-one patients with LARC were initially enrolled in the trial. Of these, 2 cases were eliminated due to distant metastasis before treatment. In addition, 4 cases were eliminated for refusing surgery after neoadjuvant chemoradiotherapy (NACRT). Finally, a total of 45 patients were treated with the sandwich NACRT plus total mesorectal excision. We followed up these patients and calculated their overall survival (OS) and disease-free survival (DFS) through a Kaplan–Meier approach. A log-rank test and multivariate survival analysis based on a Cox proportional hazard model were performed to explore the risk factors influencing distant metastasis.
Results: The median follow-up time was 60.8 months, and among the 45 patients analyzed, 1 (2.2%) patient suffered local recurrence, and 9 (20.0%) suffered distant metastasis. The 3-year OS and DFS were 95.6% and 84.4%, respectively. In addition, the 5-year OS and DFS were 91.1% and 80.0%, respectively. In the multivariate analysis, postsurgical pathological N stage and carbohydrate antigen 19–9 before treatment maintained statistical significance on distant metastasis.
Conclusions: The sandwich NACRT with XELOX regimen might reduce distant metastasis and improve the survival of LARC patients. However, long-term benefits should be verified through further Phase III clinical trials.

Keywords: rectal neoplasms, neoadjuvant chemoradiotherapy, locally advanced, neoadjuvant therapy, prognosis

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